Dapagliflozin patent dispute ends in Russia: Akrikhin keeps Fordiglif on the market

The multi-year patent dispute between AstraZeneca and Russian drugmaker Akrikhin over medicines containing dapagliflozin has ended, leaving Akrikhin free to keep producing Fordiglif. Komsomolskaya Pravda reports that the rulings are published in Russia's public arbitration case file, that the Supreme Court declined to review the earlier decisions, and that in September Akrikhin said the legal avenues for further appeal were exhausted.

How the case closed

Dapagliflozin is used in type 2 diabetes, chronic heart failure and chronic kidney disease. The originator, Forxiga, is made by AstraZeneca. Russian companies later registered their own products with the same active substance: Akrikhin's Fordiglif entered civil circulation in 2024, including the state subsidised drug provision scheme, while the litigation was still running.

In late 2025 the Intellectual Property Court confirmed Akrikhin's right to use solutions it held had passed into the public domain, and the ruling survived several instances. In 2026 the Supreme Court refused to reopen the case. The practical result for the market is continued competition between dapagliflozin products from different manufacturers.

What the cost model shows

The economics were assessed by M. A. Demidova, M. V. Zhuravleva and N. A. Petunina in a pharmacoeconomic study published in 2026 in the journal Effective Pharmacotherapy (vol. 22, No. 26). They ran a cost-minimisation analysis and a budget impact analysis comparing Fordiglif with Forxiga, using prices from the state register of maximum selling prices including VAT and weighted average wholesale mark-ups, with monotherapy and the metformin combination calculated separately.

• Weighted average annual cost of Fordiglif per patient: 24,893 roubles.
• The same therapy in combination with metformin: 29,397 roubles a year.
• About 23% below treatment with the originator dapagliflozin in the authors' model.
• Modelled population: 813,058 people with type 2 diabetes, derived from registered patient numbers and an averaged prescribing rate.
• Switching 25% of that group to the generic: savings of about 1.41 billion roubles a year.
• Full substitution within the model: about 5.62 billion roubles a year.

The authors stress that these are model outputs based on specific inputs and assumptions, not a forecast of actual state savings and not a recommendation to replace one medicine with another. Real spending depends on procurement prices, patient numbers and drug provision schemes. The figures do indicate scale: when therapy covers hundreds of thousands of people, the cost of one course becomes a systemic question.

Chronic therapy and the regulatory baseline

In chronic conditions treatment can run for years, so what matters is not only availability at a given moment but the ability to stay on the prescribed regimen. Cost shapes behaviour: patients delay the next pack, stretch supplies or look for a substitute themselves, the riskiest option. Medicines in Russia are generally prescribed by international non-proprietary name, here dapagliflozin, not by brand, so a pharmacy may hold several trade names with the same active substance. Choice and use of therapy still have to follow the physician's prescription and clinical guidance, which account for diagnosis, comorbidities and other medicines.

An originator passes the full development cycle, from molecule discovery and preclinical work to a clinical trial programme. After the statutory period of patent protection ends, other manufacturers may produce medicines with the same active substance. Generic registration requires the studies set out in legislation, with the bioequivalence clinical trial a key element comparing pharmacokinetic parameters. Economic comparison of products with one active substance is valid only when those medical and regulatory conditions are met.